BIOSTATISTICS SHARED RESOURCE Director: Motomi Mori, PhD ABSTRACT / PROJECT SUMMARY The Knight Cancer Institute (Knight) Biostatistics Shared Resource (BSR) is a cancer center managed shared resource with the overarching mission of impacting cancer through biostatistics collaboration and consulting. The BSR's vision is to provide comprehensive and integrated biostatistics support to basic, clinical, population science and translational cancer researchers at the Knight. Fostering collaboration and team-science, the BSR strives to be an integral part of cancer research teams and to provide statistical support throughout the life cycle of the research project from concept development through publication. In addition to providing support to individual researchers, the BSR provides statistical consultation to other Knight supported shared resources, and provides the biostatistics expertise and infrastructure to multi-investigator, transdisciplinary research projects. The BSR has a major role in supporting cancer clinical research, inclusive of trial design, monitoring and analysis. Finally, the BSR actively participates in education and training across the cancer research programs, through seminars and workshops, journal clubs, departmental grand rounds, and research-specific program meetings. As part of our commitment to maximize the effectiveness of the resources structure, the Knight has invested significant resources in the BSR to build expertise and capacity. This commitment is evidenced by the significant increase in operating budget from $267,015 in FY2011 (July 2010 - June 2011) to $1,394,432 in FY16 (July 2015 - June 2016). In response to large trajectory of expected growth over the next five years, a consultant was hired in September 2014 to conduct a comprehensive external evaluation that assessed user satisfaction, operational processes and procedures, and staffing. Following completion of the evaluation, the BSR developed a five-year growth and development plan to ensure high quality biostatistics support to existing investigators, as well as the large number of new investigators being recruited by the Knight. Additionally, as the Knight continues to invest in new technologies including high throughput `omics' technologies, imaging, immune monitoring and cell-based technologies, the BSR needs to be pre-emptive in understanding the data generated by the new technologies, support preprocessing and data management workflows, develop statistical analysis workflows, as well data presentation and interpretation tools. The Knight has committed to continue providing substantial resources to implement recommendations from the task force including the increased staffing to assist with business operations of the unit; development of a more robust staffing model; development of a web-based portal to easily interact and communicate with users, provide project management tools, and track staffing and usage metrics; and recruitment of additional PhD and masters level biostatisticians. Additional goals resulting from the plan include expanding phase I design expertise; integration of biostatistics staff into the disease specific research teams to improve early collaboration with investigators; and coordination with computational biology and the Integrated Genomic Shared Resource to create a seamless pipeline for omics data analysis support. In early 2015 the Knight expanded its collaboration with Cancer Research And Biostatistics (CRAB), a non-profit entity located in Seattle, Washington. As the long-standing statistical and data coordinating center for SWOG, CRAB is a national leader in designing, managing and analyzing therapeutic and preventive cancer clinical trials. The collaboration with CRAB has greatly enhanced our capacity and scope of expertise. The relationship has provided Knight clinical and translational researchers with immediate access to experienced, senior cancer biostatisticians with expertise including multi-site clinical trials, phase III trial designs, and early detection trials. The BSR is directed by Cancer Prevention and Control member Motomi (Tomi) Mori, PhD. The BSR is highly utilized by cancer researchers and consistently demonstrates key scientific contributions. Between 2011 and 2015, the BSR provided biostatistics support to 124 cancer researchers from all four research programs.